CurrentMass General Brigham Health PlanPolicy 077

Amtagvi (lifileucel) — Coverage Criteria and Prior Authorization

Clinical coverage and prior authorization requirements for Amtagvi (lifileucel), an autologous tumor-infiltrating lymphocyte therapy, for treatment of unresectable or metastatic melanoma for Mass General Brigham Health Plan members and specified plan variations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAmtagvi (lifileucel) — Coverage Criteria and Prior Authorization

Policy CodePolicy 077

Change TypeMaterial updates to prior authorization routingadded evidence summaryoperational variations

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation demonstrating all initial approval criteria (age ≥18, unresectable/metastatic melanoma with BRAF testing, prior PD‑1 therapy, resectable metastasis ≥1.5 cm, ECOG 0–1, required labs and tests) before administering Amtagvi.

SourceLink

POLICY UPDATE CHANGES

Added variation for One Care and Senior Care Options (SCO) members referencing CMS and MassHealth guidance for medical necessity determinations.

Updated prior authorization table to reflect authorization required for multiple plan types and to note Prime Therapeutics and MassHealth processes.

Summary of evidence added describing pivotal trials (C-144-01) and supporting studies and FDA accelerated approval with postmarketing trial requirement.

Single courseAuthorized duration of therapy

ECOG 0-1Required performance status

≥1.5 cm

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Min lesion size to harvest TILs

Uveal/ocular melanomaExplicit exclusion

FDA accelerated (Feb 2024)Regulatory status

Coverage Criteria for Amtagvi (lifileucel)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria

Age 18 or older
B: Diagnosis of unresectable or metastatic melanoma (Stage IIIC or Stage IV) with BRAF mutation testing
C: Progression of disease following anti–PD‑1–based therapy (e.g., nivolumab, pembrolizumab)
D: If BRAF V600 mutation is present, progression following BRAF inhibition (e.g., vemurafenib, dabrafenib, encorafenib)
E: At least one metastasis with diameter ≥ 1.5 cm is resectable>= 1.5 cm
F: ECOG performance status of 0 or 1ECOG 0-1
G: Adequate hematologic, liver, and renal function within the past 3 months: ANC >1,000/mm3; hemoglobin >9 g/dL; platelets >100,000/mm3; ALT/AST <5× ULN; estimated GFR >40 mL/minlaboratory criteria as listed
H: Negative testing for HIV within the past 6 months
I: Negative antibody testing for hepatitis B or C, or undetectable viral load within the past 6 months
J: If known or suspected heart disease, echocardiogram within the past 6 months shows LVEF ≥45%LVEF >=45%
K: If known or suspected lung disease, pulmonary function testing within the past 6 months shows FEV‑1 >60% predictedFEV-1 >60%
L: Treatment will be administered in an Amtagvi Authorized Treatment Center

The following conditions are explicit exclusions or contraindications for Amtagvi (lifileucel) and must be confirmed absent before authorization: organ allograft; prior cell transfer therapy; diagnosis of uveal/ocular melanoma; known hypersensitivity to lifileucel; symptomatic and/or untreated brain metastases; chronic systemic steroid therapy; active systemic infections; evidence of liver or kidney dysfunction; receipt of a live or attenuated vaccine within 28 days of planned non‑myeloablative lymphodepletion; left ventricular ejection fraction (LVEF <45%); forced expiratory volume in 1 second (FEV-1 ≤ 60% predicted); other primary malignancies unless in remission ≥ 3 years; and primary immunodeficiency.

Amtagvi is authorized as a single treatment course only. Per policy, additional courses of lifileucel are considered experimental/investigational and not medically necessary and requests for repeat courses may be denied unless supported by evidence consistent with this policy.

Regimen	Indication	Coverage status
Lifileucel (Amtagvi) autologous tumor‑infiltrating lymphocyte (TIL) therapy — single treatment course
For adult patients with unresectable or metastatic (Stage IIIC or Stage IV) cutaneous melanoma who have progressed after anti–PD‑1–based therapy; if BRAF V600 mutation is present, progression after prior BRAF inhibition is required
Covered when all initial approval criteria are met; additional courses considered experimental/investigational and not medically necessary

Coding and Key Eligibility Values

Informational HCPCS codes included in policyHCPCS

J3490	Unclassified drugs.
J3590	Unclassified biologics

inv-05: Resectable metastasis size — 6 1.5 cm

Resectable metastasis sizeAt least one metastasis with diameter ≥ 1.5 cm (resectable)

ContextRequirement is part of initial approval criteria (Criterion E)

Documentation neededMedical record must document tumor measurement showing ≥ 1.5 cm and resectability

inv-06: ECOG performance status — 0-1

ECOG performance statusECOG PS 0 or 1 required for coverage

ContextListed as criterion F in initial approval criteria

Implication

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Amtagvi (lifileucel) for Commercial, Mass General Brigham ACO, Medicare Advantage, One Care, and Senior Care Options (SCO) members. For Commercial and Qualified Health Plans, prior authorization is managed by Prime Therapeutics; see the Prime Therapeutics policy for medical necessity criteria. For Mass General Brigham ACO members, prior authorization is managed by the MassHealth Drug Utilization Review Program — submit requests to MassHealth DUR and refer to Table 75: T-Cell Immunotherapies for criteria.

Commercial & Qualified Health Plans: prior auth managed by Prime Therapeutics
Mass General Brigham ACO: prior auth managed by MassHealth DUR — submit to MassHealth DUR
Medicare Advantage, One Care, SCO: prior authorization required

Step Therapy

Step therapy is not applicable. Coverage is determined by meeting the documented clinical eligibility criteria (see Initial Approval criteria) rather than by a step-therapy sequence.

Salvage and Line-of-Therapy Positioning

salvage

Line of therapy: Patients must have progressed following anti–PD‑1 therapy; if BRAF V600+, must have progressed after BRAF inhibition

Biomarker and Testing Requirements

inv-18: BRAF V600 — testing requirement/value

Required testBRAF V600 mutation testing is required as part of initial diagnosis criteria; if BRAF V600 positive, prior progression after a BRAF inhibitor is required

RoleDetermines prior therapy requirement: presence of BRAF V600 mandates prior BRAF inhibition before lifileucel

DocumentationMedical record must include BRAF V600 test result to support coverage determination

Definitions

inv-16: TIL therapy — Tumor-infiltrating lymphocyte (TIL) therapy definition

DefinitionTumor-infiltrating lymphocyte (TIL) therapy: a tumor-derived autologous T cell immunotherapy in which lymphocytes are harvested from a patient’s tumor and used as an autologous cellular therapy

Example (policy agent)Amtagvi (lifileucel) is an autologous TIL therapy indicated for unresectable or metastatic melanoma after PD-1 blockade

Coverage implicationPolicy covers a single treatment course of autologous TIL therapy (lifileucel) when all initial criteria are met; additional courses are considered experimental/investigational

Background

Amtagvi (lifileucel) is an autologous tumor‑infiltrating lymphocyte (TIL) therapy for adult patients with unresectable or metastatic melanoma who have progressed after anti–PD‑1 therapy; patients with a BRAF V600 mutation must also have progressed after BRAF inhibitor therapy. Authorization requires that patients meet specific clinical and laboratory criteria including age ≥18, at least one resectable metastasis with diameter ≥ 1.5 cm, ECOG performance status 0–1, adequate hematologic and organ function (eg, ANC > 1,000/mm3, hemoglobin > 9 g/dL, platelets > 100,000/mm3, eGFR > 40 mL/min), negative HIV and hepatitis testing, and administration at an Amtagvi Authorized Treatment Center. The policy notes FDA accelerated approval and that the therapy is provided as a single course with confirmatory postmarketing trials required.

Policy Revision History

2026-01-01ad_hoc_reviewLatest

Updated prior authorization table and added variation for One Care and SCO members.

2025-04-01ad_hoc_review

MassHealth variation updated to include new prior authorization process; references to MassHealth prior auth routing clarified.

2025-03-01ad_hoc_review

Policy Summary

PayerMass General Brigham Health Plan

PolicyAmtagvi (lifileucel) — Coverage Criteria and Prior Authorization

Policy CodePolicy 077

Change TypeMaterial updates to prior authorization routingadded evidence summaryoperational variations

Effective DateMay 1, 2024

Next Review DateN/A

SourceLink

On This Page

Patients with ECOG >1 do not meet this coverage requirement

inv-07: Absolute neutrophil count — > 1,000 / mm3

Absolute neutrophil count (ANC)> 1,000/mm3 required within the past 3 months

ContextPart of adequate hematologic parameters in initial approval criteria (Criterion G.1)

DocumentationRecent lab results (within 3 months) must be provided in the medical record

inv-08: Hemoglobin — > 9 g/dL

Hemoglobin (Hgb)> 9 g/dL required within the past 3 months

ContextSpecified as part of adequate hematologic parameters (Criterion G.2)

DocumentationProvide recent hemoglobin laboratory values in authorization request

inv-09: Platelets — > 100,000 / mm3

Platelet count> 100,000/mm3 required within the past 3 months

ContextListed under adequate hematologic parameters in initial approval criteria (Criterion G.3)

DocumentationInclude recent platelet count in supporting labs for prior authorization

inv-10: Estimated GFR — > 40 mL/min

Estimated glomerular filtration rate (eGFR)> 40 mL/min required within the past 3 months

ContextPart of adequate renal function in initial approval criteria (Criterion G.5)

DocumentationProvide recent eGFR or creatinine-based renal function testing in authorization materials

Documentation Required

Required Clinical Documentation

Medical record documentation must demonstrate that ALL initial approval criteria are met prior to authorization. Required documentation includes, but is not limited to: patient age, diagnosis of unresectable or metastatic melanoma with BRAF mutation testing results, prior treatment history showing progression after anti–PD-1 therapy (and BRAF inhibitor if V600 mutation present), evidence of at least one metastasis ≥1.5 cm that is resectable, ECOG performance status, recent laboratory results (hematologic, liver, renal), HIV and hepatitis testing results, relevant cardiac or pulmonary testing when indicated (LVEF, FEV‑1), and documentation that treatment will occur at an Amtagvi Authorized Treatment Center.

BRAF mutation testing results
Documented progression after anti–PD-1 therapy (e.g., nivolumab, pembrolizumab)
If BRAF V600 mutation present: documented progression after BRAF inhibitor therapy (eg, vemurafenib, dabrafenib, encorafenib)
Evidence of metastasis ≥1.5 cm and resectability
ECOG PS 0–1
Recent labs meeting specified thresholds (ANC, hemoglobin, platelets, ALT/AST, eGFR)
HIV and hepatitis B/C testing or undetectable viral load within 6 months
Echocardiogram (LVEF ≥45%) if heart disease suspected; pulmonary function (FEV‑1 >60%) if lung disease suspected
Treatment location: Amtagvi Authorized Treatment Center

Denial Risk

Documentation Insufficiency and Repeat Course

Requests lacking complete documentation that ALL initial approval criteria are satisfied will be delayed or denied per policy. Specifically, insufficient evidence of age, diagnosis with BRAF testing, prior therapy history (anti‑PD‑1 and BRAF inhibitor when applicable), laboratory values, infection screening, cardiac/pulmonary testing when indicated, or confirmation of treatment at an authorized center will result in requests being returned for additional information or denied. Additional courses beyond a single treatment course are considered experimental/investigational and will be denied; only a single treatment course meets approval criteria.

Incomplete documentation will prompt request for additional information or denial
Additional courses of Amtagvi are considered experimental/investigational and are not approved

Summary of evidence added and references updated to include pivotal and supporting studies for lifileucel.

2025-02-01annual_review

Added MassHealth Variation to policy.

2024-05-01effective_date

Policy effective; initial incorporation of clinical coverage criteria for lifileucel (Amtagvi).